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Evaluation of BIO-101 versus placebo for treating severe sarcopenia in elderly patients with reduced mobility

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on sarcopenia, a condition that causes loss of muscle mass and strength in elderly people. The research evaluates a new medication called BIO101 (also known as 20-hydroxyecdysone) in elderly patients who have severe sarcopenia and experience difficulty with movement. The purpose is to determine if this treatment can help prevent major mobility disability in older adults who are still able to live independently but are experiencing declining physical function.

During the study, participants will receive either BIO101 capsules at a dose of 700 milligrams per day (divided into two daily doses) or placebo capsules. The treatment will continue for up to 36 months. The medication is taken by mouth, and the study will monitor how well participants maintain their ability to move around and perform daily activities.

The research will measure several aspects of physical function, including walking speed, hand grip strength, and overall quality of life related to muscle strength. These measurements will help determine if the medication is effective in maintaining mobility and strength in elderly people with sarcopenia. The study is designed to be double-blind, which means neither the participants nor the researchers directly working with them will know who is receiving the actual medication or the placebo.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your physical performance will be measured using the Short Physical Performance Battery (SPPB) test

    You will complete a 400-meter walk test, which must be finished within 15 minutes

    Your hand grip strength will be measured using special equipment

    Your walking speed will be evaluated during a 4-meter walking test

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either BIO-101 or a placebo

    Neither you nor your healthcare provider will know which treatment you are receiving

  3. Step 3

    Treatment period

    You will take BIO-101 350 mg or placebo capsules twice daily by mouth

    The treatment period will continue for 52 weeks (one year)

    You will continue living at home and maintaining your regular daily activities during this time

  4. Step 4

    Regular assessments

    Your walking ability will be regularly tested using the 4-meter walking test

    Your hand grip strength will be measured periodically

    You will complete quality of life questionnaires about how sarcopenia affects your daily activities

    Your mobility will be monitored throughout the study to track any significant changes

  5. Step 5

    Final evaluation

    After 52 weeks, final measurements will be taken of your walking speed, hand grip strength, and physical performance

    You will complete a final quality of life assessment

    Your overall mobility status will be evaluated

Who can join the trial?

10 criteria

  • Must be 65 years or older
  • Must be living independently at home and able to walk outside
  • Must have experienced a decrease in ability to move around over the past year
  • Must score between 3 and 7 on the Short Physical Performance Battery (SPPB) test, which measures lower body strength and walking ability
  • Must be able to walk 400 meters (about 1/4 mile) within 15 minutes without:
    • Sitting down
    • Help from another person
    • Using a walker (using a cane is allowed)
    • Must have hand grip strength measurements below:
      • For men: less than 35.5 kilograms in dominant hand
      • For women: less than 20 kilograms in dominant hand
      • Must have a walking speed of 0.8 meters per second or slower during a 4-meter walking test (approximately 13 feet)

Who cannot join the trial?

15 criteria

  • Age below 65 years
  • Already experiencing significant mobility disability (inability to walk 400 meters)
  • Severe neurological conditions that affect movement
  • Uncontrolled diabetes (high blood sugar levels)
  • Recent heart attack or stroke (within past 3 months)
  • Severe heart failure or unstable heart conditions
  • Active cancer treatment
  • Severe kidney or liver disease
  • Taking medications that can interact with the study drug
  • Participation in another clinical trial in the past 30 days
  • Planned surgery during the study period
  • Severe mental health conditions that could affect participation
  • Alcohol or substance abuse
  • Pregnancy, breastfeeding, or planning to become pregnant
  • Unable to provide informed consent
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Investigated drugs

BIO-101 is an investigational medication being studied for treating sarcopenia, which is a condition characterized by loss of muscle mass and strength in elderly people. This oral medication is being tested to see if it can help prevent major mobility disability in older adults who have sarcopenia but are not yet disabled. The medication aims to help maintain muscle function and physical performance in elderly patients.

What is already known about the treatment

BIO-101 – An investigational oral medication administered twice daily (350 mg) that is currently being studied in Phase 3 clinical trials for the treatment of sarcopenia, a condition characterized by loss of muscle mass and strength in elderly patients. The drug is being evaluated for its potential to prevent major mobility disability in older adults with sarcopenia, representing a novel therapeutic approach in geriatric medicine. While the exact molecular mechanism is still under investigation in clinical trials, BIO-101 is being developed as a targeted therapy to address muscle-related conditions in the elderly population.

Investigated diseases

Sarcopenia - A progressive muscle condition characterized by the gradual loss of muscle mass, strength, and function that occurs with aging. This condition typically develops slowly over several years and primarily affects older adults. Sarcopenia leads to decreased physical performance, making everyday activities like walking, climbing stairs, or carrying objects more difficult. The condition often results in reduced mobility and can affect a person's ability to maintain balance. Muscle loss occurs throughout the body but is particularly noticeable in the legs and arms.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2022-502417-28-01Protocol codeBIO101-CL07Estimated enrolment932 patientsSponsorBiophytis

sourced from the EU Clinical Trials Register and site verification

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